Effects of MET on PPDH, Neck Pain and Disability After Cesarean Section

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05834140

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to determine the effect of Muscle Energy Techniques on post dural puncture headache, neck pain and disability after Cesarean Section.

Condition or Disease	Intervention/Treatment	Phase
Post-Dural Puncture Headache Cesarean Section Complications	Other: Traditional Physical Therapy Other: Muscle Energy Technique	N/A

Detailed Description

Caesarean section (CS) is the worldwide process of pregnancy termination that delivers live or dead fetuses with an incision on the abdominal wall and uterine wall.

It is performed under neuraxial anesthesia (spinal and epidural anesthesia). Post- dural puncture headache (PDPH) is a major complication of neuraxial anesthesia which presents as a dull throbbing pain in a frontal-occipital distribution, aggravates on sitting or standing, and is reduced by lying down.

This study will be a randomized clinical trial. Subjects with PPDH meeting the predetermined inclusion and exclusion criteria will be divided into two groups: i.e. treatment and control group. Both groups will receive baseline treatments i.e. (heating pads & TENS). In addition, treatment group will receive post-isometric relaxation of METs. Each subject will receive a total of 4 treatment sessions, with 2 treatment sessions per day

Pre-treatment will be done at day 1 and post-treatment will be done at day 2, using Headache Disability Index (HDI), Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI) as subjective measurements. Recorded values will be analysed for any change using SPSs

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Muscle Energy Technique on Post-Dural Puncture Headache, Neck Pain and Disability After Cesarean Section

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Traditional physical therapy TENS and Heating pads	Other: Traditional Physical Therapy TENS (transcutaneous electrical nerve stimulation) on continuous mode at 80-120 Hz for 15-20 min and Heating pads for 10-15 min Total 4 sessions will be given in 2 days
Experimental: Muscle Energy Technique Muscle Energy Technique protocol in along with TENS and Heating pads	Other: Muscle Energy Technique Muscle energy technique (Post Isometric relaxation) along with TENS and Heating pads. MET of the scaleni MET of Sternocleidomastoid MET of Levator Scapulae MET of Upper fibers of Trapezius Total 4 sessions will be given in 2 days

Arm

Intervention/Treatment

Active Comparator: Traditional physical therapy

TENS and Heating pads

Other: Traditional Physical Therapy

TENS (transcutaneous electrical nerve stimulation) on continuous mode at 80-120 Hz for 15-20 min and Heating pads for 10-15 min Total 4 sessions will be given in 2 days

Experimental: Muscle Energy Technique

Muscle Energy Technique protocol in along with TENS and Heating pads

Other: Muscle Energy Technique

Muscle energy technique (Post Isometric relaxation) along with TENS and Heating pads. MET of the scaleni MET of Sternocleidomastoid MET of Levator Scapulae MET of Upper fibers of Trapezius Total 4 sessions will be given in 2 days

Outcome Measures

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS) [2nd day]
Numeric pain rating scale (NPRS) is an outcome measure that is a segmented numeric version of visual analogue scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient's pain. The common format is horizontal bar or line and NPRS is anchored by terms describing pain and severity extremes
Neck Disability Index [2nd day]
The NDI is a 10-item scaled self-administered questionnaire covering pain, concentration, and activities of daily living. Each of the ten items is scored from 0 to 5, and the total is calculated and multiplied by two to produce a percentage score of the maximal score; higher score indicates greater disability. Vernon and Mior defined 0-8 as none, 10-28 as mild, 30-48 as moderate, 50-68 as severe, and over 68 as complete disability
Headache Disability Index [2nd day]
The Henry Ford Hospital Headache Disability Questionnaire (HDI) is a 25-item questionnaire that examines the effects of headache on daily life. This questionnaire has a two-factor structure emotionally and functionally. Scoring (No: 0, Sometimes:2, Yes:4) varies between 0 and 100. The higher the score, the more headache disability

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18 to 40 years
Both Primiparous and multiparous
Both elective and emergency Lower Section Cesarean Section
Headache occurring within 24-72 hours post C-section
Headache aggravates on getting in upright position

Exclusion Criteria:

History of Trauma/fracture of head and neck region
History of cervical spine surgery
Had previous diagnostic Lumbar Puncture (LP)
Any kind of infection, malignancy, inflammation and structural deformity present in head and neck region.
Other serious forms of headaches including Migraine, Cluster, thunderclap, hypnic etc.
Cervical Radiculopathies and spondylolisthesis